Senior Clinical Research Coordinator
The Massachusetts General Hospital Division of Gastroenterology is seeking a highly motivated individual to manage innovative clinical research through the MGH Crohn's and Colitis Center. The Division's multidisciplinary staffing structure and project portfolio support professional growth of clinical research staff at all levels as well as successful facilitation of interventional trials and genetic, longitudinal, and observational studies.
The position will support sponsor- as well as investigator-initiated clinical trials and research studies in field of gastroenterology with a specific focus on inflammatory bowel diseases. The individual in this role will coordinate clinical research and manage all aspects of the clinical trial pipeline, including data monitoring and sharing, IRB communication, patient care coordination, and budgeting. The Senior CRC will also be responsible for recruitment, regulatory documentation, and management of clinical research activities within the Gastrointestinal Division and the MGH Crohn's and Colitis Center, including all activities necessary to effectively start, conduct, and end specified projects.
The ideal candidate would be a self-motivated team player with superb time management, attention to detail, organizational and communication skills, as well as intellectual independence and initiative. The ability to work both independently and as part of a team on multiple complex and dynamic projects is essential to this job, as are the willingness to learn new skills and think innovatively to address challenges. PRINCIPLE DUTIES AND RESPONSIBILITIES:
- Initiate and manage trials and research studies, including budget development, protocol submission for approval from Partners Human Research Committee, and facilitation of review and execution of Clinical Trials Agreements through Partners Clinical Research Office
- Work with PI to implement and oversee data management and prepare study-related reports for various committees, funding organizations, regulatory agencies, and safety monitoring.
- Monitor enrollment performance for subject accession and data acquisition in accordance with the protocols and convey this information to the PI on a regular basis
- Maintain regulatory documentation in accordance with IRB regulations and prepare IRB submissions including amendments, continuing reviews, adverse events, and new protocol submissions
- Liaising with human subjects research committee members, core laboratories, site investigators, and study staff for maintaining continuous high quality and efficiency of standard operating procedures.
- Working in close concert with Principal Investigator and participating physicians to screen, consent and enroll eligible study patients
- Managing the operation of study visits and serves as liaison to study participants on scheduling, remuneration, and study-related questions
- Field site questions and, in consultation with the PI, provide protocol clarifications daily via telephone, fax, e-mail and surface mail
- Working in close collaboration with the grants managers to monitor expenditures and ensure projects proceed quickly and within budget and payments due are collected from sponsor
- Working in close collaboration with Patient Billing Manager, Research Compliance, and Research Finance to ensure study-related procedures are billed appropriately and corrections are made promptly, if necessary
- Monitor and report adverse events and other major concerns related to the studies and disseminate the information to the PI, Medical Monitor, FDA and Steering Committee
- Develop protocols and consent forms in accordance with scientific goals, IRB regulations, and logistical considerations, as needed
- Perform literature reviews, provide analysis support, and help with the preparation of manuscripts
- Create operations manuals and case report forms, as needed
- Coordinate use of Research Pharmacy and Clinical Research Centers, as needed
- Assist with training and supervision of CRC I's, as needed
- Perform other administrative support duties as required
MA-Boston-MGH Main Campus Work Locations
MGH Main Campus
55 Fruit Street
Boston 02114 Job
Massachusetts General Hospital (MGH) Schedule
Full-time Standard Hours
Day Job Employee Status
Regular Recruiting Department
MGH GI Division Qualifications :QUALIFICATIONS:
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
- Must be able to work independently and display initiative to introduce innovations to research studies
- Excellent communication and organizational skills
- Pays very careful attention to detail
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs
- Must have the ability to identify problems and develop solutions, prioritize tasks and set deadlines, and prepare and monitor budgets.
- Ability to manage multiple tasks and workstreams simultaneously
- Proficiency in Microsoft office
- Staff member will be trained in phlebotomy and collection of vital signs
Staff member will obtain training in: CITI, GCP, IATA, phlebotomy, and vital signs EDUCATION:
Minimum of a Bachelor's Degree required; Master's degree preferred.EXPERIENCE:
Minimum of 3 years of directly related experience working on clinical trials or sponsor-investigator initiated trials. Experience with research IRB committees and submission processes is required. FISCAL RESPONSIBILITY:
Work with MGH CRO to create trial budgets, independently manage aspect of trial budgets including invoicing, payments, and reporting.WORKING CONDITIONS:
Works primarily in an office setting and in the clinical environment of the GI department. May be required to attend and travel to meetings outside of regularly scheduled hours. May be required to report to the hospital outside of normal business hours to assist with events that require emergency management.